A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas

Sponsor

Mayo Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02104310

Collaborator

Brains Together for the Cure (Other)

Enrollment

Location

Arm

203

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of this study is to compare the 18F-DOPA PET/CT scan with the MRI scan for identifying where the disease is that needs to be treated with radiation.

Condition or Disease	Intervention/Treatment	Phase
Malignant Glioma	Drug: Fluorine-18-L-dihydroxyphenylalanine	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study Evaluating the Utility of 18F-DOPA PET for Radiotherapy Treatment Planning of Malignant Glioma Patients

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Mar 26, 2021

Anticipated Study Completion Date :

Mar 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluorine-18-L-dihydroxyphenylalanine 18F-DOPA PET imaging will be used to guide radiotherapy treatment volumes and patients will be followed post-treatment to analyze response and patterns of failure	Drug: Fluorine-18-L-dihydroxyphenylalanine 5 millicuries ± 10%; Intravenous injection; 1 time Other Names: 18F-DOPA FDOPA

Arm

Intervention/Treatment

Experimental: Fluorine-18-L-dihydroxyphenylalanine

18F-DOPA PET imaging will be used to guide radiotherapy treatment volumes and patients will be followed post-treatment to analyze response and patterns of failure

Drug: Fluorine-18-L-dihydroxyphenylalanine

5 millicuries ± 10%; Intravenous injection; 1 time

Other Names:

18F-DOPA

FDOPA

Outcome Measures

Primary Outcome Measures

Treatment volume comparison [6 weeks]
The primary endpoint for this pilot study will be to compare radiotherapy treatment volumes defined by conventional MR-only with treatment volumes defined with both 18F-DOPA PET and conventional MR information

Secondary Outcome Measures

Advanced imaging volume comparison [6 weeks]
For patients who have advanced MRI scans performed as part of standard clinical care, advanced MRI volumes will be compared with conventional MRI volumes as well as 18F-DOPA PET volumes
Concordance with recurrence [up to 10 years]
For patients who progress radiographically within the observation period of this study will compare concordance of recurrence locations with pre-treatment 18F-DOPA PET uptake

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥7 years.
Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma.
CT simulation, 18F-DOPA PET imaging, and standard of care pre-radiotherapy MRI scans to be performed at Mayo Clinic Rochester.
Willing to sign release of information for any follow-up records.
Provide informed written consent.

Exclusion Criteria:

Patients diagnosed with WHO grade IV malignant glioma.
Patients previously treated with radiation therapy.
Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure).
Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson's Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception